EP3167804B1 - Gestion de glucose sanguin - Google Patents

Gestion de glucose sanguin Download PDF

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Publication number
EP3167804B1
EP3167804B1 EP16207531.1A EP16207531A EP3167804B1 EP 3167804 B1 EP3167804 B1 EP 3167804B1 EP 16207531 A EP16207531 A EP 16207531A EP 3167804 B1 EP3167804 B1 EP 3167804B1
Authority
EP
European Patent Office
Prior art keywords
lancet
strip
biological
cover
station
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Active
Application number
EP16207531.1A
Other languages
German (de)
English (en)
Other versions
EP3167804A1 (fr
Inventor
Curtis Christensen
Daniel Davis
Erik Davis
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Pops! Diabetes Care Inc
Original Assignee
Pops! Diabetes Care Inc
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Filing date
Publication date
Application filed by Pops! Diabetes Care Inc filed Critical Pops! Diabetes Care Inc
Publication of EP3167804A1 publication Critical patent/EP3167804A1/fr
Application granted granted Critical
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Active legal-status Critical Current
Anticipated expiration legal-status Critical

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/150007—Details
    • A61B5/150374—Details of piercing elements or protective means for preventing accidental injuries by such piercing elements
    • A61B5/150534—Design of protective means for piercing elements for preventing accidental needle sticks, e.g. shields, caps, protectors, axially extensible sleeves, pivotable protective sleeves
    • A61B5/150572—Pierceable protectors, e.g. shields, caps, sleeves or films, e.g. for hygienic purposes
    • A—HUMAN NECESSITIES
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    • A61B5/14—Devices for taking samples of blood ; Measuring characteristics of blood in vivo, e.g. gas concentration within the blood, pH-value of blood
    • A61B5/1405—Devices for taking blood samples
    • A61B5/1411—Devices for taking blood samples by percutaneous method, e.g. by lancet
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    • A61B5/145—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue
    • A61B5/14532—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue for measuring glucose, e.g. by tissue impedance measurement
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    • A61B5/15146—Devices loaded with multiple lancets simultaneously, e.g. for serial firing without reloading, for example by use of stocking means.
    • A61B5/15148—Constructional features of stocking means, e.g. strip, roll, disc, cartridge, belt or tube
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    • A61B5/15157—Geometry of stocking means or arrangement of piercing elements therein
    • A61B5/15159—Piercing elements stocked in or on a disc
    • A61B5/15163—Characterized by propelling the piercing element in an axial direction relative to the disc
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    • A61B5/157—Devices characterised by integrated means for measuring characteristics of blood
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    • A61B5/7405—Details of notification to user or communication with user or patient ; user input means using sound
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    • A61B5/7455—Details of notification to user or communication with user or patient ; user input means characterised by tactile indication, e.g. vibration or electrical stimulation
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Definitions

  • a lancet device can include a base that includes a support surface, a lancet and a cover.
  • the cover can include a peripheral edge along which the cover is connected to the base, a cover region, a lancet aperture, and a peripheral hinge near the peripheral edge.
  • the cover region can cover the lancet when the cover is in an un-depressed position.
  • the lancet can be configured to protrude through the lancet aperture when the cover is in a depressed position.
  • the peripheral hinge can facilitate controlled movement of the cover from the un-depressed position to the depressed position upon application of a predetermined depression force.
  • the biological test kit can include a reusable module and a disposable module.
  • the disposable module can include one or more lancet devices, such as those described elsewhere herein, and one or more strip stations.
  • the strip station can support one or more biological test strips that can interact with the collected biological sample.
  • the reusable module can support measuring equipment that can measure a property of the biological sample.
  • a reusable module connector and a disposable module connector may removably connect the reusable module and the disposable module.
  • a display monitor can be included with the reusable module to display the measured property.
  • Embodiments of the invention include a lancet device 100 to collect biological samples.
  • the lancet device 100 can include a base 102, a lancet 104, and a cover 106.
  • the base 102 can include a support surface 108.
  • the base 102 can be made of a material that is rigid in comparison to the cover 106.
  • the base 102 can be made of materials such as a rigid polymer, metal, etc.
  • the base 102 can be of any desired size or shape.
  • the base 102 may be operably coupled to the cover 106.
  • the support surface 108 may be a generally planar surface that can house the lancet 104.
  • the support surface 108 in the illustrated embodiment is an upper surface of the base 102.
  • the support surface 108 can be made of similar materials as the base 102 and can be rigid in comparison to the cover 106.
  • a lancet device 100 such as those discussed elsewhere herein can be used for collecting blood from a user for monitoring glucose.
  • the lancet device 100 can be used for collecting similar biological samples.
  • a user can apply a force on the cover region 120.
  • the force applied by the user can be due to finger pressure.
  • the force applied on the cover region 120 may increase as indicated by the force ramp during stages 1-2 in FIG. 6 .
  • the cover 106 can move from an un-depressed position in which the cover region covers the lancet to a depressed position during stage 2-3 in FIG. 6 .
  • the lancet 104 protrudes through the lancet aperture 132 in the depressed position and exposes biological fluid.
  • a quantity of the biological fluid as the biological sample can be collected during stages 3-4 in FIG. 6 .
  • the reusable module 210 can include a display monitor 218 supported by the reusable module housing 212 and configured to display the measured property.
  • the display monitor 218 can be a LCD panel or LED or similar display device that can display the measured property and/or other relevant information.
  • the display monitor 218 can be supported by the reusable module housing 212 by any of the known methods, including microfabrication techniques.
  • the display monitor 218 is a rectangular panel of diagonal length "w.” It may be appreciated that the display monitor 218 can be of any desired size or shape to display the measured property (e.g., as alphanumeric characters).
  • the display monitor 218, for instance, can display blood glucose level as a numerical value in milligrams per deciliter, when the biological test kit 200 collects blood from users for diabetes management.
  • some biological test kits can have other numbers of lancet stations and/or strip stations.
  • some embodiments include four lancet stations (e.g., the biological test kit 200 of FIG. 11 ).
  • Some embodiments include different numbers of lancet stations, such as three, five, six, and so on.
  • Some embodiments include different numbers of strip stations, such as three, five, six, and so on.
  • the number of lancet stations is equal to the number of strip stations. Such embodiments can facilitate one use of a lancet station for each strip station.
  • the reusable module 210 can include a wireless transmitter supported by the reusable module housing 212.
  • the wireless transmitter can be configured to transmit a signal representative of the measured property to a separate device for display.
  • the wireless transmitter can be a Bluetooth transmitter that can interface with a mobile device that is adapted with a Bluetooth receiver, or any similar transmission device.
  • the mobile device may be a cell phone or tablet devices that can receive signals transmitted wirelessly, and store the measured property.
  • the disposable module 220 can include an insulin delivery device connector 234 supported by the disposable module housing 222 as shown in FIG. 13 .
  • the insulin delivery device connector 234 can be configured to detachably connect the disposable module 220 to an insulin delivery device 230.
  • the insulin delivery device connector 234 can be supported by any of the top, bottom, front, back or lateral surfaces of the disposable module housing.
  • the insulin delivery device connector 234 can be a clip, latch, hook-and-loop fastener or similar mechanism that can removably connect with an insulin delivery device 230.
  • the insulin delivery device connector 234 can be an adhesive coating or film.
  • the insulin delivery device 230 can be an insulin storage container with a syringe 232 for delivering insulin in users who monitor and manage blood glucose levels.
  • the strip station cover 474 can be removably connected to the disposable module housing 422.
  • the strip station cover can be configured to cover the recess 472 and prevent access to the first biological strip 462 when in a covered position.
  • the strip station cover 474 can be configured to permit access to the first biological strip 462 when in an uncovered position.
  • the strip station cover 474 can be removably connected to the disposable module housing 422 by mechanical fasteners or adhesives.
  • the strip station cover 474 can be a film containing an adhesive to removably connect to the disposable module housing 422.
  • the strip station cover 474 can be peeled to remove the adhesive connection between the strip station cover 474 and the disposable module housing 422. In the illustrated embodiment shown in FIG.
  • strip station cover 474 prevents access to the first biological strip 462 in a covered position.
  • a second biological strip 460 can be accessed when a corresponding strip station cover is in an uncovered position.
  • FIGs. 16 and 17 show the strip station cover 474 according to some embodiments.
  • the strip station cover 474 includes a groove that is configured to engage with the disposable module housing 422 by a friction fit.
  • the first and second strip stations 450 and 452 are located on the disposable module 420.
  • the biological test kit 400 can be fabricated as a single component without two modules that can be removably connected (E.g.: the disposable and the reusable module forming a single module). In such an embodiment, the strip station cover 474 forms a friction fit with the single module.
  • a biological test kit such as those discussed elsewhere herein can be used for managing blood glucose by periodically testing blood glucose levels.
  • the biological test kit can include a lancet device such as those discussed elsewhere herein.
  • the lancet device can be used to collect a quantity of a biological sample, such as blood from the user.
  • a biological test strip such as glucose strips supported by a strip station can interact with the collected biological sample by electro-chemical or other means.
  • the lancet device and the strip station can be supported by a disposable module.
  • Measuring equipment supported on a reusable module can measure a biological property, such as blood glucose level in milligrams per deciliter.
  • a display monitor supported on the reusable module can display the measured blood glucose level.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Physics & Mathematics (AREA)
  • Engineering & Computer Science (AREA)
  • Molecular Biology (AREA)
  • General Health & Medical Sciences (AREA)
  • Biophysics (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Medical Informatics (AREA)
  • Veterinary Medicine (AREA)
  • Surgery (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pathology (AREA)
  • Public Health (AREA)
  • Hematology (AREA)
  • Dermatology (AREA)
  • Emergency Medicine (AREA)
  • Optics & Photonics (AREA)
  • Geometry (AREA)
  • Manufacturing & Machinery (AREA)
  • Measurement Of The Respiration, Hearing Ability, Form, And Blood Characteristics Of Living Organisms (AREA)

Claims (13)

  1. Kit de test biologique (200 ; 300 ; 400) comprenant :
    (a) un module réutilisable (210 ; 310 ; 410) comprenant (i) un boîtier de module réutilisable (212 ; 312 ; 412) (ii) un équipement de mesure (214 ; 314 ; 414) supporté par le boîtier de module réutilisable (212 ; 312 ; 412) et configuré pour mesurer une propriété d'un échantillon biologique, et (iii) un connecteur de module réutilisable (216 ; 316 ; 416) supporté par le boîtier de module réutilisable (212 ; 312 ; 412) ;
    (b) un module jetable (220 ; 320 ; 420) comprenant (i) un boîtier de module jetable (222 ; 322 ; 422), (ii) une première station de lancette (240 ; 340 ; 440) supportée par et fixe par rapport au boîtier de module jetable (222 ; 322 ; 422), la première station de lancette (240 ; 340 ; 440) étant configurée pour faciliter la génération d'un premier échantillon biologique et comprenant un dispositif de lancette (100) comprenant une lancette (104) et un couvercle (106) qui se déplace entre une position non enfoncée dans laquelle le couvercle (106) recouvre la lancette (104) et une position enfoncée dans laquelle la lancette (104) fait saillie à travers une ouverture de lancette (132) dans le couvercle (106) ; (iii) une première station de bande (250 ; 350 ; 452) supportée par le boîtier de module jetable (222 ; 322 ; 422) et comprenant une première bande biologique (260 ; 360 ; 462) configurée pour recevoir le premier échantillon biologique et pour fournir le premier échantillon biologique à l'équipement de mesure (214 ; 314 ; 414) afin de mesurer la propriété ; et (iv) un connecteur de module jetable (226 ; 326 ; 426) supporté par le boîtier de module jetable (222 ; 322) et pouvant être raccordé, de manière modulaire au connecteur de module réutilisable (216 ; 316 ; 416).
  2. Kit de test biologique (200) selon la revendication 1, dans lequel le boîtier de module jetable (222) comprend (A) un premier boîtier de sous-module (280) qui supporte la première station de lancette (240) et comprend un premier connecteur de sous-module (282) et (B) un second boîtier de sous-module (290) qui supporte la première station de bande (250) et comprend un second connecteur de sous-module (292) qui peut être raccordé, de manière modulaire, au premier connecteur de sous-module (282).
  3. Kit de test biologique (200 ; 400)) selon la revendication 1, dans lequel le module jetable (220) comprend en outre (v) une seconde station de lancette (242 ; 442) supportée par et fixe par rapport au boîtier de module jetable (222 ; 422), la seconde station de lancette (242 ; 442) étant configurée pour faciliter la génération d'un second échantillon biologique et comprenant un dispositif de lancette (100) comprenant une lancette (104) et un couvercle (106) qui se déplace entre une position non enfoncée dans laquelle le couvercle (106) recouvre la lancette (104) et une position enfoncée dans laquelle la lancette (104) fait saillie à travers une ouverture de lancette (132) dans le couvercle (106) et (vi) une seconde station de bande (252 ; 450) supportée par le boîtier de module jetable (222 ; 422) et comprenant une seconde bande biologique (262 ; 460) configurée pour recevoir le second échantillon biologique et pour fournir le second échantillon biologique à l'équipement de mesure (214 ; 414) pour la mesure de la propriété.
  4. Kit de test biologique (200 ; 300 ; 400) selon la revendication 1, dans lequel le connecteur de module jetable (226 ; 326 ; 446) et le connecteur de module réutilisable (216 ; 316 ; 416) comprennent ensemble une fixation de verrouillage.
  5. Kit de test biologique (300) selon la revendication 1, dans lequel la première station de bande (350) comprend une fente (354) dans le boîtier de module jetable (322) et un récipient de bande (356) positionné dans la fente (354), le récipient de bande (356) étant configuré pour coulisser à l'intérieur et à l'extérieur de la fente (354) entre une position fermée et une position ouverte et étant adapté pour fournir l'accès à la première bande biologique (360) lorsqu'il est dans la position ouverte.
  6. Kit de test biologique (400) selon la revendication 1, dans lequel la première station de bande (452) comprend : un évidement (472) défini dans le boîtier de module jetable (422) configuré pour maintenir la première bande biologique (462), et
    un couvercle de station de bande (474) raccordé, de manière amovible, au boîtier de module jetable (422), le couvercle de station de bande (474) étant configuré pour recouvrir l'évidement (472) et empêcher l'accès à la première bande biologique (462) lorsqu'elle est dans une position couverte et pour permettre l'accès à la première bande biologique (462) lorsqu'elle est dans une position découverte.
  7. Kit de test biologique (200 ; 400) selon la revendication 1,
    dans lequel le module jetable (220 ; 420) comprend en outre (vi) une seconde station de bande (252 ; 450) supportée par le boîtier de module jetable (222 ; 422) et comprenant une seconde bande biologique (262 ; 460) configurée pour recevoir un second échantillon biologique et pour fournir le second échantillon biologique à l'équipement de mesure afin de mesurer la propriété, et
    dans lequel l'équipement de mesure (214 ; 414) comprend un mécanisme de corrélation configuré pour identifier un échantillon biologique mesuré comme provenant de la première station de bande (250 ; 452) ou de la seconde station de bande (252 ; 450).
  8. Kit de test biologique (200 ; 400) selon la revendication 7, dans lequel l'équipement de mesure (214 ; 414) est configuré pour fournir l'échantillon biologique mesuré provenant la première station de bande (250 ; 452) ou de la seconde station de bande (252 ; 260) à un écran d'affichage (218 ; 418) pour l'affichage.
  9. Kit de test biologique (200 ; 300 ; 400) selon la revendication 1, dans lequel le kit de test biologique a une épaisseur globale inférieure à un centimètre.
  10. Kit de test biologique (200 ; 300 ; 400) selon la revendication 1, dans lequel le module réutilisable (210 ; 310 ; 410) comprend en outre (iv) un écran d'affichage (218 ; 318 ; 418) supporté par le boîtier de module réutilisable (212 ; 312 ; 412) et configuré pour afficher la propriété mesurée.
  11. Kit de test biologique (200 ; 300 ; 400) selon la revendication 1, dans lequel le module réutilisable (210 ; 310 ; 410) comprend en outre (iv) un émetteur sans fil supporté par le boîtier de module réutilisable (212, 312 ; 412) et configuré pour transmettre un signal représentatif de la propriété mesurée à un dispositif séparé pour l'affichage.
  12. Kit de test biologique (200 ; 300 ; 400) selon la revendication 1, dans lequel le module réutilisable (210 ; 310 ; 410) comprend en outre (iv) un connecteur de boîtier de dispositif mobile supporté par le boîtier de module réutilisable (212, 312 ; 412) et configuré pour raccorder, de manière détachable, le module réutilisable (210 ; 310 ; 410) avec un boîtier de dispositif mobile.
  13. Kit de test biologique (200) selon la revendication 1, dans lequel le module jetable (220) comprend en outre (iv) un connecteur de dispositif de distribution d'insuline (234) supporté par le module jetable (220) et configuré pour raccorder, de manière détachable, le module jetable (220) avec un dispositif de distribution d'insuline (230).
EP16207531.1A 2013-04-29 2014-04-25 Gestion de glucose sanguin Active EP3167804B1 (fr)

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
US201361817172P 2013-04-29 2013-04-29
US13/946,838 US9237866B2 (en) 2013-04-29 2013-07-19 Blood glucose management
PCT/US2014/035507 WO2014179171A1 (fr) 2013-04-29 2014-04-25 Gestion de la glycémie
EP14726304.0A EP2991553B1 (fr) 2013-04-29 2014-04-25 Gestion de la glycémie

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EP (2) EP3167804B1 (fr)
CN (1) CN105377136B (fr)
AU (2) AU2014260194B2 (fr)
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WO2014179171A1 (fr) 2014-11-06
US20160120452A1 (en) 2016-05-05
AU2018256521A1 (en) 2018-11-22
US20180035936A1 (en) 2018-02-08
US20240000353A1 (en) 2024-01-04
US9237866B2 (en) 2016-01-19
AU2014260194B2 (en) 2018-11-22
US20160100785A1 (en) 2016-04-14
US20200375517A1 (en) 2020-12-03
EP3167804A1 (fr) 2017-05-17
CN105377136B (zh) 2018-02-16
AU2018256521B2 (en) 2019-01-03
EP2991553A1 (fr) 2016-03-09
CN105377136A (zh) 2016-03-02
CA2909364A1 (fr) 2014-11-06
EP2991553B1 (fr) 2017-02-15
AU2014260194A1 (en) 2015-12-10
US20140323915A1 (en) 2014-10-30

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